Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
Mayo Clinic
Summary
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.
Description
PRIMARY OBJECTIVE: I. To determine if salvage SBRT is non-inferior to moderately hypofractionated radiation therapy regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) grade 3 or higher within 2-years. EXPLORATORY OBJECTIVES: I. After completion of radiation therapy, determine the incidence of: Ia. Disease free survival (DFS), defined as the first occurrence of new clinical failure (local recurrence, regional recurrence, or distant metastasis) after salvage radiation therapy (RT); Ib. Grade 2 or greater GU and GI toxicity at 3 years \[Common Terminology Criter…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma at the time of surgery * Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \[AJCC\] Criteria 8th edition \[Ed.\]) * PSA post radical prostatectomy ≥ 0.1 and \< 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment * Patients must sign institutional review board (IRB) approved study specific informed consent * Patients must complete all…
Interventions
- DrugAntiandrogen Therapy
Receive ADT
- ProcedureBiospecimen Collection
Undergo blood sample collection
- RadiationHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
- ProcedurePositron Emission Tomography
Undergo PET scan
- RadiationStereotactic Body Radiation Therapy
Undergo SBRT
- OtherSurvey Administration
Ancillary study
- ProcedureMagnetic Resonance Imaging
Locations (6)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic Health System in Albert LeaAlbert Lea, Minnesota
- Mayo Clinic Health System - MankatoMankato, Minnesota
- Mayo Clinic in RochesterRochester, Minnesota
- Mayo Clinic Health System-Eau Claire ClinicEau Claire, Wisconsin
- Mayo Clinic Health System-Franciscan HealthcareLa Crosse, Wisconsin